DOE Graded Approach. IAEA January 23-27, 2012 Meeting

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1 DOE Graded Approach IAEA January 23-27, 2012 Meeting Duli C. Agarwal (301) Office of Quality Assurance (HS-33) Office of Nuclear Safety U.S. Department of Energy

2 Driver of Graded Approach 10 C.F.R. Part requires: Where appropriate, a contractor must use a graded approach to implement the requirements of this part, document the basis of the graded approach used, and submit that document to DOE. 2

3 Definition of Graded Approach 10 C.F.R states: Graded approach means the process of ensuring that the level of analysis, documentation, and actions used to comply with a requirements in this part commensurate with: 1. The relative importance to safety, safeguards, and security; 2. The magnitude of any hazard involved; 3

4 Definition of Graded Approach (continued) 3. The life cycle stage of a facility; 4. The programmatic mission of a facility; 5. The particular characteristics of a facility; 6. The relative importance of radiological and non-radiological hazards; and 7. Any other relevant factor. 4

5 Grading Process Grading is a management process for determining the degree of rigor, or effort (resources), which needs to be applied to QA program implementation. Multiple factors such as cost, schedule, environment, health and safety, mission, public perception, and security should be considered and taken into account when grading quality requirements. At a minimum the process includes: Identifying risk Identifying specific requirements to be applied Determining depth, extent, and degree of rigor in the application of requirements Assigning quality levels Specifying the applicable controls Documenting the basis for the graded approach 5

6 Graded Approach The general Quality Level system consists of four levels: Quality Level 1 is the highest and demands the highest level of rigor equates to Safety Class Quality Level 2 is the next highest and requires a slightly lower rigor equates to Safety Significant Quality Level 3 is the next lowest and is used for components not credited in a safety basis document, but have quality significance Quality Level 4 is commercial quality or very low risk affecting items and services. 6

7 Graded Approach Examples The graded approach establishes the rigor in the design and review processes. For Safety Significant (Quality Level 2) designs, the following occurs: All design calculations have rigorous documented second checks by qualified engineers Design reviews are held with formal comment resolution Configuration management is applied throughout the life of the design. 7

8 Graded Approach Examples (continued) For Non-Safety Significant (Quality Level 3) designs, the following occurs: All design calculations have rigorous documented second checks by qualified engineers Informal design reviews are held with comment resolution as part of the document approval process Configuration management may or may not be applied throughout the life of the design. 8

9 Graded Approach Examples (continued) Several valves are being procured, two are safety significant (SS) and two are not. The two SS (Quality Level 2) valves will require: An on-site audit of the manufacturer with a potential source inspection during testing. Certified material test reports provided by the supplier for all pressure-boundary materials A thorough receiving inspection based on instructions from the system and quality engineers 9

10 Graded Approach Examples (continued) The two non-ss (Quality Level 3) valves will require: To be procured from a qualified supplier that may be the manufacturer or a qualified distributor. The supplier qualification will be a desk evaluation rather than an on-site audit Receiving inspection may be limited to verifying the part number, size, and lack of shipping damage. 10

11 Challenges Inconsistent application of graded approach on DOE programs. DOE programs have different definitions of the multiple quality levels. Inconsistent application of multiple quality levels makes it harder to communicate lessons learned between programs. 11

12 Contact Information Duli Agarwal, Office of Quality Assurance at Questions? 12

Accepting Supplier ISO 9000 Quality Programs

Accepting Supplier ISO 9000 Quality Programs IEEE Subcommittee on Qualification October 7-8, 2004 Leigh A. Aparicio PSE Technical Leader aparicio@epri.com Project Overview ISO 9000 Phase I Initiated in